PART 7Amendment of Part 7 (Traditional Herbal Registrations)
F1Substitution of regulation 144 (obligation following new herbal monograph)I1127
For regulation 144 substitute—
144
1
Paragraph (2) applies where a new herbal monograph of the kind referred to—
a
in the case of a THR (NI) or THR (UK), in Article 16h(3) of the 2001 Directive, or
b
in the case of a THR (GB), in regulation 143A,
is established.
2
Where this paragraph applies, the holder of the THR(GB), THR(NI) or THR(UK) to which the monograph relates must as soon as is reasonably practicable—
a
consider whether to modify the registration dossier; and
b
notify any modification to the licensing authority.